Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Apobiologix is a division of Apotex that works closely and in-depth with multiple global vendors in a virtual environment to deliver biopharmaceutical projects from inception to commercialization by co-development or in-licensing.
As an Apobiologix team member, provide Apobiologix division with technical support for Chemistry Manufacturing and Controls (CMC) related activities for biopharmaceuticals in the pipeline according to national and international regulatory expectations. Provide technical support for life cycle management activities for the commercial products, interacting closely with the Global Quality and Regulatory teams that support Apobiologix.
•Provide technical support for Apobiologix commercial products’ life cycle management (PLCM) activities including but not limited to change control processes, interacting effectively with QA and RA teams
•Review change control documents from Contract Manufacturing Organisations, or Contract Development and Manufacturing Organisations (third parties) for accuracy and completeness of information provided. Also review and ensure that all documents that are required to support the proposed changes are provided.
•Supports the QA team for smooth and efficient initiation of change controls in the Quality Management System.
•Support the planning, execution and monitoring of activites related to the CMC of new and existing Apobiologix products, such as method development, validation for release, stability testing of characterisation, biosimilarity studies, tech transfers and device changes.
•Participate in the writing and review of Quality and CMC sections of Common Technical Documents (CTDs), relating to analytical methods development, qualification, validation, characterization and biosimilarity studies for Apobiologix projects.
•Perform project management activites related to the CMC or PLCM of Apobiologix projects such as tracking, monitoring and reporting on status of change controls, and develop project management tools to support those activities, as required.
•Identify and communicate any gaps, risks or issues promptly and works to resolve them in a timely manner.
•Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, Safe Work Procedures (SWPs) and Safety Charter.
•Participation in other technical assignments and internal projects as needed.
•Works in a safe manner collaborating as a team member to achieve all outcomes.
•Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
•Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
•All other relevant duties as assigned.
oMasters degree in Biochemistry, Biotechnology or analytical chemistry or related fields
•Knowledge, Skills and Abilities
oBroad understanding of biopharmaceuticals manufacturing and in-depth knowledge of biochemistry and protein analytical chemistry as applied to CMC related aspects of biopharmaceutical development.
oKnowledge of and practical experience with national and international regulatory requirements as they relate to the manufacture and analysis of biopharmaceutical drugs in compliance with current Compendia, Pharmacopoeia, ICH and GMP requirements.
oShould be highly organized, excellent attention to details and have ability to multitask when needed
oDemonstrated proficiency in written and verbal English communication.
oDemonstrates necessary interpersonal skills to effectively and efficiently work collaboratively with a broad range of colleagues, international partners and vendors.
o3+ years of technical experience in biopharmaceuticals analysis and / or manufacturing in a regulated biopharmaceutical environment
oExperience with Quality Management System (like Trackwise) will be an asset
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
from Apotex – Research & Development https://ift.tt/2Nxu9q0
Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.
Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.
Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.
The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.